Medically reviewed on December 1, Do not use Revlimid during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study, bronchoalveolar cancer and opaque cells.
Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used especially cancer and heart disease pregnancy, it may cause birth defects or embryo-fetal death. Females of reproductive potential must use 2 forms of effexor and alcohol consumption or continuously abstain from heterosexual sex during and for 4 weeks after Revlimid treatment [see Warnings and Precautions 5, bronchoalveolar cancer and opaque cells.
Hematologic Toxicity Neutropenia and Thrombocytopenia. Revlimid can cause significant neutropenia and thrombocytopenia. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter.
Revlimid has demonstrated a significantly increased risk of deep vein thrombosis DVT and pulmonary embolism PEas well as risk of myocardial infarction constipation and asthma stroke in patients with multiple myeloma who were treated with Revlimid and dexamethasone therapy.
Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling.
Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma MM. Revlimid is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediaterisk myelodysplastic syndromes MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Revlimid is indicated for the treatment of patients with mantle cell lymphoma MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Revlimid is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions 5.
Revlimid should be taken orally at about the same time each day, either with or without food. Revlimid capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed. The recommended starting dose of Revlimid is 25 mg orally once daily on Days of repeated day cycles in combination with dexamethasone.
Refer to Section Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a Revlimid-containing therapy [see Warnings and Precautions 5. Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to Revlimid.
The recommended starting dose of Revlimid is 10 mg once daily continuously Days of repeated day cycles until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated, bronchoalveolar cancer and opaque cells. The recommended starting dose of Revlimid is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.
Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:. Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows:. Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows:. Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to Revlimid.
Base subsequent Revlimid dose increase or decrease on individual patient treatment tolerance [see Dosage and Administration 2. Revlimid can cause fetal harm when administered to a pregnant female. Limb abnormalities birth control and period seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis.
This effect was seen at all doses tested. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus [see Warnings and Precautions 5.
Revlimid is contraindicated in patients who have demonstrated severe hypersensitivity e. Revlimid is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes life-threatening human birth defects or embryo-fetal death [ see Use in Specific Populations 8.
An embryo-fetal development study in monkeys indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during bronchoalveolar cancer and opaque cells, similar to birth defects observed in humans following exposure to thalidomide during pregnancy.
Females of Reproductive Potential Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning Revlimid therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with Revlimid, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of Revlimid therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within days and the second test within 24 hours prior to prescribing Revlimid therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles [see Use in Specific Populations 8.
Males Lenalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Revlimid and for up to 4 weeks after discontinuing Revlimid, even if they have undergone a successful vasectomy. Male patients taking Revlimid must not donate sperm [see Use in Specific Populations 8. Blood Donation Patients must not donate blood during treatment with Revlimid and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to Revlimid.
Because of the embryo-fetal risk [see Warnings and Precautions 5. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding. Patients taking Revlimid should have their complete blood counts assessed bronchoalveolar cancer and opaque cells as described below [see Dosage and Administration 2. Patients taking Revlimid for MDS should have their complete blood counts monitored weekly for the first 8 weeks and at least monthly thereafter.
Patients taking Revlimid for MCL should have bronchoalveolar cancer and opaque cells complete blood counts monitored weekly for the first cycle 28 daysbronchoalveolar cancer and opaque cells, every 2 weeks during cyclesand then monthly thereafter.
In the newly diagnosed multiple myeloma Bronchoalveolar cancer and opaque cells study in which nearly all patients received antithrombotic prophylaxis, DVT was reported as a serious adverse reaction 3. In the NDMM study, myocardial infarction including acute was reported as a serious adverse reaction 2.
Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize arthritis and lymphoma modifiable factors e. In controlled clinical trials that did not use concomitant thromboprophylaxis, The median time to first thrombosis event was 2. In the NDMM study in which nearly all patients received antithrombotic prophylaxis, the overall frequency of thrombotic events was The median time to first thrombosis event was 4.
Instruct patients to report immediately any signs and symptoms suggestive of thrombotic events. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision in patients receiving Revlimid [see Drug Interactions 7.
In a prospective randomized 1: In an interim analysis, there were 34 deaths among patients on the Revlimid treatment arm compared to 18 deaths among patients in the chlorambucil treatment arm, and hazard ratio for overall survival was 1.
The trial was halted for safety in July Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure occurred more frequently in the Revlimid treatment arm. Revlimid is not indicated and not recommended for use in CLL outside of controlled clinical trials.
The incidence of hematologic plus solid tumor excluding squamous cell carcinoma and basal cell carcinoma SPM was Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3. Patients being sick and diabetes received Revlimid-containing therapy until disease progression did not show a higher incidence of invasive SPM than patients treated in the fixed duration Revlimid-containing arms, bronchoalveolar cancer and opaque cells.
Monitor patients for the development of second primary malignancies. Take into account both the potential benefit of Revlimid and the risk of second primary malignancies when considering treatment with Revlimid. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. Hepatic failure, including fatal cases, has occurred in patients treated with lenalidomide in combination with dexamethasone.
The mechanism of drug-induced hepatotoxicity is unknown, bronchoalveolar cancer and opaque cells. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors.
Monitor liver enzymes periodically. Stop Revlimid upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive Revlimid.
Revlimid interruption or discontinuation should be considered for Grade skin rash. Fatal instances of tumor lysis syndrome have been reported during treatment with lenalidomide. The patients at risk of tumor lysis syndrome are those with high tumor burden prior bronchoalveolar cancer and opaque cells treatment.
These patients should be monitored closely and appropriate precautions taken. Tumor flare reaction has occurred during investigational use of lenalidomide for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash. Tumor flare reaction may mimic progression of disease PD. All of the events occurred in cycle 1 and bronchoalveolar cancer and opaque cells patient developed TFR again in cycle In patients who are auto-HSCT candidates, bronchoalveolar cancer and opaque cells, referral to a transplant center should occur early in treatment to optimize the timing bronchoalveolar cancer and opaque cells the stem cell collection.
Measure chlorella and blood pressure studies function before start of Revlimid treatment and during therapy.
The following adverse reactions are described in detail in other sections of the prescribing information:, bronchoalveolar cancer and opaque cells. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Data bronchoalveolar cancer and opaque cells evaluated from patients in a large phase 3 study who received at least one dose of Revlimid with low dose dexamethasone Rd given for 2 different durations of time i. The median treatment duration in the Rd Continuous arm was In general, the most frequently reported adverse reactions were comparable in Arm Rd Continuous and Arm Rd18, and included diarrhea, anemia, constipation, bronchoalveolar cancer and opaque cells, peripheral edema, neutropenia, fatigue, bronchoalveolar cancer and opaque cells, back pain, bronchoalveolar cancer and opaque cells, asthenia, and insomnia.
The most frequently reported Grade 3 or 4 reactions included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, bronchoalveolar cancer and opaque cells, back pain, hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia.